On June 15, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the pricing of an upsized underwritten follow-on offering of 7,000,000 shares of common stock at a price to the public of $16.00 per share (Press release, Arcellx, JUN 15, 2022, View Source [SID1234616018]). The offering was upsized to 7,000,000 shares of Arcellx’s common stock from the original offering size of 4,000,000 shares. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx, are expected to be $112 million. In addition, Arcellx has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of common stock on the same terms and conditions. The offering is expected to close on June 21, 2022, subject to the satisfaction of customary closing conditions. All of the shares in the proposed offering will be sold by Arcellx.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BofA Securities, SVB Securities, William Blair and Canaccord Genuity are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective today. The offering is made only by means of a prospectus, copies of which may be obtained, when available, from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]. William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687, or by email at [email protected]; or Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, 12th Floor, Boston, MA 02110, or by telephone at (617) 371-3900, or by email at [email protected]. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On July 15, 2022 Paige, a global leader in clinical AI applications in pathology, reported a collaboration with Janssen Research & Development, LLC (Janssen) to evaluate the potential of a hematoxylin and eosin (H&E)-based, artificial intelligence (AI)-powered biomarker test to predict the presence of certain actionable alterations in the fibroblast growth factor receptor (FGFR) genes in patients with advanced urothelial cancer, also known as bladder cancer (Press release, Paige AI, JUN 15, 2022, View Source [SID1234616016]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This biomarker test, developed by Janssen, is a first-of-its-kind screening tool to predict the occurrence of actionable genomic alterations. The goal is to improve rates of confirmatory molecular testing and accelerate recruitment of patients into biomarker-driven clinical trials that are enrolling patients with certain tumor FGFR mutations.

Bladder cancer is the tenth most common cancer worldwide1, and approximately 15% of people with advanced disease have alterations in the FGFR gene.2,3 Currently, most patients with bladder cancer do not have their tumors sequenced to identify potential genomic alterations and potentially inform more targeted treatment decisions. For those who are tested, results from today’s confirmatory molecular FGFR tests can take weeks to be returned to the ordering physician, slowing time to trial enrollment and treatment. Leveraging existing H&E data to provide guidance for care can reduce barriers for clinical trial recruitment by providing results for a digitized image of a routine biopsy in less than one hour.

The technology is currently being evaluated in Janssen’s clinical trials to screen for FGFR gene alterations in adult patients with advanced urothelial cancer using the Paige Platform, a comprehensive digital pathology software platform that is inclusive of an FDA-cleared and CE-marked viewer and storage capabilities that is compatible with existing digital pathology solutions, including most scanners, monitors, and laboratory information systems (LIS). As more clinical trial sites adopt a digital pathology workflow, Paige will be able to support local testing.

"We are excited to mark a new chapter in deploying Janssen’s AI technology in a clinical setting to efficiently detect biomarkers, in this case some rare gene mutations and fusions," said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. "With the global deployment of our Paige Platform underway, we will make our capability broadly available in support of the clinical development of targeted and other classes of therapeutic drugs and patient identification for future biomarker and drug development programs."

On June 15, 2022 Imagia Canexia Health, a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions, reported the CE-IVD marking for its Imagia Canexia Health Insights Platform (ICHIP) to operate across Europe (Press release, Canexia Health, JUN 15, 2022, View Source [SID1234616015]). ICHIP provides intricate molecular and computational genome analysis, from targeted next-generation sequencing (NGS) data, for individual cancer patients. The company offers a unique clinical solution for European oncologists to quickly generate reports—including therapeutic and clinical trial recommendations. This new approval furthers Imagia Canexia Health’s mission to combine advanced genomics, oncology, artificial intelligence, and informatics to enable health systems to provide cost-effective testing in-house—thus delivering precision cancer treatments to patients no matter where they live.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinicians receive next-generation sequencing (NGS) data sourced from human tissue or blood samples. These insights are collected, as well as processed, on Illumina’s NextSeq and MiSeq devices. Then, ICHIP uses AI to detect and analyze genomic variants, match interpretations, identify potential clinical trials, as well as generate a cancer-treatment results report. This creates a new ability to integrate clinical and genomic patient data, augmenting treatment decisions by oncologists. With this crucial information, health professionals can rapidly access data about a cancer patient’s genetics, as well as describe the potential associations between detected variants and specific therapeutics, all while making the most informed care-management decisions.

"Achieving the CE-IVD mark, a highly regarded standard around the globe, represents an important milestone that reflects the technological quality and rigor upon which we built the Imagia Canexia Health Insights Platform (ICHIP)," said Imagia Canexia Health CEO Geralyn Ochab. "Our company takes pride in the platform’s ability to quickly provide specialists with vital information to fight cancer, now supporting European oncologists with life-saving information for their patients."

On June 15, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, reported that it will report financial results for the fourth quarter and fiscal year 2022 before the market open on Tuesday, July 12, 2022 (Press release, AngioDynamics, JUN 15, 2022, View Source [SID1234616014]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13730672.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 12, 2022, until 11:59 p.m. ET on Tuesday, July 19, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13730672.

On June 15, 2022 Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide reported that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market LLC ("Nasdaq") on Thursday, June 16, under the new ticker symbols "ALVO" and "ALVOW", respectively (Press release, Alvotech, JUN 15, 2022, View Source [SID1234616013]). This follows the successful completion of the company’s business combination with Oaktree Acquisition Corp. II ("OACB"), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"). The merger, which was approved on June 7 by OACB shareholders, creates a publicly traded, pureplay company focused on the growing global biosimilar market.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The public listing is expected to be the largest debut on a U.S. exchange by an Icelandic company. Ordinary shares of the company are also expected to trade on the Nasdaq First North Growth Market in Iceland commencing on June 23, 2022. Alvotech is expected to be the first dual-listed Icelandic company on both a U.S. and Icelandic stock exchange.

"Becoming a public company is a historic milestone on Alvotech’s growth journey," said Robert Wessman, founder and Executive Chairman of Alvotech. "We expect that becoming a listed company will allow us to continue strengthening our position in the biosimilar space while delivering value to our partners and patients across the globe."

"Oaktree is proud to be associated with Alvotech, a world-class biosimilar platform with a mission-critical focus on providing important drugs at a reduced cost," said Howard Marks, Co-Founder and Co-Chairman of Oaktree. "We look forward to the continuation of our relationship as the company enters its next phase of growth."

Since its inception a decade ago, Alvotech has built a vertically integrated, state-of-the-art platform for developing and manufacturing biosimilars at scale. Biosimilars are therapeutic equivalents to biologics, a rapidly growing category of highly efficacious medicines, that provide lower-cost alternatives to higher-priced originator medicines. Biologics represent over 40% of all pharmaceutical spending in the U.S. and over 30% of spending on medicines in Europe at list prices1. Alvotech’s current portfolio of eight products and product candidates targets multiple therapeutic areas and represents an estimated total addressable market of over $85 billion based on estimated peak sales of the reference products2.

Alvotech’s lead product, AVT02 (adalimumab), a biosimilar to Humira, has launched in Canada and Europe and is expected to launch in the U.S. on July 1, 20233. For the U.S. market, Alvotech is pursuing an interchangeability designation for AVT02 (adalimumab) and has previously announced FDA acceptance of Alvotech’s BLA supporting interchangeability for the company’s high-concentration, citrate-free biosimilar candidate. More recently, the company has announced positive topline results for AVT04 (ustekinumab), Alvotech’s proposed biosimilar to Stelara, for both the confirmatory clinical, safety and efficacy study and a pharmacokinetic (PK) study.

In order to give its products global reach with local expertise, Alvotech has formed strategic commercialization partnerships with leading pharmaceutical companies spanning global markets. These include partnerships with Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) for the US market; STADA Arzneimittel AG for EU and select other territories; and Fuji Pharma Co., Ltd (TSE: 4554) for Japan, among others.

The transaction is supported by a PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. The PIPE was backed by top-tier investors such as Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

To celebrate the public listing, Mr. Wessman will ring the opening bell at NASDAQ with live ceremonies beginning at 9:15 ET on June 16 at the Nasdaq Market Site in New York City. The event will be livestreamed and can be viewed at View Source